Control device with recommendations

ABSTRACT

The invention relates to a control device suitable for suggesting control instructions to the patient in order to facilitate the use thereof.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a United States national stage application ofthe PCT patent application PCT/IB2015/050646 filed on Jan. 28, 2015designating the United States, and claims foreign priority to Frenchpatent application FR 1450706 filed on Jan. 29, 2014, and also claimsforeign priority to European patent application EP 14152955.2 filed onJan. 28, 2014, the contents of all three documents being herewithincorporated by reference in their entirety.

FIELD OF THE INVENTION

The present invention discloses a medical treatment system and a methodof using such a system comprising a control device suitable forcontrolling a medical device. It can be a control device comprising aninterface making it possible to easily monitor and/or control a fluiddelivery device.

STATE OF THE ART

Some treatments require the use of a delivery device which can becontrolled by a control device (distinct or not from the deliverydevice), the two devices forming a medical treatment system. Thedelivery device can further make it possible to inject a medicine (painrelief, insulin, etc) or another fluid on or in the body of a patient.In the context, for example, of the treatment of a diabetic, a patientcan use an insulin pump which will continuously and/or occasionallydeliver a certain quantity of insulin.

The insulin-dependent diabetics, also called type 1 diabetics, no longerphysiologically produce insulin. These people are therefore forced totrack, with careful attention, their blood glucose and accurately andmeticulously parameterize their insulin delivery device. This type ofdiabetes thus requires a device that provides them with a verycomprehensive range of treatment options in order to monitor theirsickness and live the best possible life.

There is another type of diabetes, called type 2 diabetes. The latter ischaracterized by an increase in resistance of the organism to insulinand a reactional hyper-insulinemia. The pancreas produces increasinglymore insulin until it is exhausted and when the quantity of insulin isno longer sufficient to counter the resistances, the blood glucosebecomes abnormally high. Type 2 diabetes can also require the use of aninsulin delivery device. In this document, a delivery device should beunderstood to mean a delivery device comprising a tank and a pumpingmechanism controlled by an electronic processor on the basis ofinstructions given by a control device. The PCT patent applicationsbearing the following numbers WO 2007/113708 A1 and WO 2014/009876 A2respectively disclose a delivery device and a control device (comprisinga communication securing mechanism), the full content of which should beconsidered to form part of the present application. However, the peopleafflicted with this type of diabetes are generally less disposed to usesuch a treatment system because it is too complicated to use. In effect,type 2 diabetics are generally more elderly, less at ease with the newtechnologies and are often from a socio-cultural background that isproportionally more under-privileged.

Generally, the existing treatment systems are very complex, requiringtraining and often hospitalization at the time of initialization of thetreatment to carefully monitor the correct control of the system by thepatient. This type of system is disclosed by the US patent applicationsUS2006/272652 A1, US2005/192557 A1, US2010/185181 A1 or US2013/096530 A1which are incorporated in this application for reference. These systemsare restrictive and cannot be accessible to the whole world because oftheir complexity. For example, adapting a pre-prandial bolus accordingto the quantity of carbohydrates (to be estimated by the patient) whichwill be ingested, an option known by the name of “bolus calculator”,remains an action that is very little used by some diabetics because ofits complexity. Thus, these devices may not be suited to certain peopledespite the known advantages of these systems.

GENERAL DESCRIPTION OF THE INVENTION

The present invention is described and characterized by the independentclaim or claims, whereas the dependent claims describe other features ofthe invention.

The present application claims the priority of the application bearingthe following number EP14152955.2, filed on 28 Jan. 2014 in the name ofDebiotech SA, the full content of which should be considered to formpart of the present application.

The physiological and psychological characteristics are specific to eachpatient and are found to be highly heterogeneous between the members ofa particular population (for example type 2 diabetics). Ideally, atreatment system should be suited to each patient in order to control aspecific treatment taking into account all or some of his or herphysiological and psychological characteristics. In order to offer sucha system, the present invention discloses a control device comprising aninterface that is easy to use, intuitive and it makes it possible tolimit the manipulation errors. Ideally, the device offers such aninterface without in any way neglecting the options and tools that allowfor the best treatment of certain diseases or disabilities. The devicecan also, in one of its embodiments, incorporate a reminderfunctionality: in the case where the user might have forgotten certainsteps of his or her treatment, the system can remind him or her thereofand provide a recommendation on the procedure to follow. Furthermore,the interface can be specifically edited for a patient taking intoaccount his or her needs and his or her capabilities. Preferentially,the control device can enable the user to control a delivery device byusing a specific incrementation rule.

The invention described in this document presents a control devicesuitable for controlling a treatment system which preferentiallycomprises a device for delivering a fluid to a patient. The controldevice can be distinct or not from the delivery device. In other words,the treatment system comprises a delivery device and a control device,these two devices can be arranged in one and the same casing or in twodistinct casings and separate from one another. For example, thedelivery device can be affixed to the body of the patient whereas thecontrol device can be a remote control more or less remote from thedelivery device. The control device can also be a personal computer. Inall cases, the two devices (delivery device and control device) aresuitable for exchanging information (data, instructions, etc) betweenthem by wired or wireless means, for example via a radio communication,IR, etc). This communication can be one-way (from the control device tothe delivery device) or two-way (at least between said devices).

The delivery device can be configured to deliver (but without beinglimited thereto) insulin, morphine, hydromorphone, bupivacain,clonidine, other analgesics, genetic agents, antibiotics, nutrientfluids, analgesics, hormones or hormonal medicines, gene therapymedicines, anticoagulants, cardio-vascular medicines or chemotherapyagents.

The control device is designed to control, check and/or monitor thedelivery device. The control device comprises a display device and/or aninput device (for example a touch screen) making it possible:

-   -   for the user to act on the system in order to control        instructions (edit data, select or activate options and/or send        commands for example: order the delivery of a fluid according to        a flow rate, a quantity and/or a duration); and/or    -   for the system to inform, alert, propose commands, prompt and/or        recommend instructions to the user.

In this document, a user can be a patient, a doctor, a nurse, a personlinked to the patient (a parent, a tutor, etc). Each type of user canhave specific rights in the parameterizing and for the control of thesystem. For example, a doctor will be able to have access to certainparameterizings of the system whereas the patient does not have thesesame access rights. In this document, the prescriber is the user withthe greatest number of access rights, the prescriber is preferentially aperson different from the patient, for example a doctor, a nurse or apharmacist.

It is particularly preferable to have this type of distinction when thepatient does not have the capability or the competences or the knowledgeneeded for the correct control of the system. In the case where theperson is not familiarized with the modern control devices, this type ofsystem can make it possible for this person to have a simple andintuitive control offering only controls that he or she really needs.

According to a first aspect of the invention, a treatment systemcomprises at least two distinct interfaces. In this document, the term“interface” should be understood to mean: a device allowing for theexchange of information between a user and an electronic system (forexample, the control device or, more generally, the treatment system).This device can comprise an input device and a display device. The inputdevice can enable a user to send (inform, notify) information to theprocessing system and the display device can enable the system to send(inform, notify) information to the user. In the case where the systemcomprises a touch screen, the input and display devices are at leastpartially combined in the touch screen. The first interface isaccessible only to a prescriber and the second interface is accessibleto another type of user (for example the patient or the tutor of apatient). The access to at least one interface can be secured and lockedby a password or specific token (bar code, fingerprint, RFID chip, pincode, etc). The first interface allows access to a greater number ofparameterizings. Thus, for example, a doctor can edit certain values oractivate options that the patient will not be able to modify because ofhis or her limited access rights.

Furthermore, it is particularly advantageous to limit certainfunctionalities of the control device in the case where the fluidadministered might be dangerous to the patient. Thus, the patient willbe limited in his or her controls in order to avoid him or heradministering or controlling, knowingly or unknowingly, a lethal dose(for example, if the fluid is insulin).

In one embodiment, these two interfaces can be present on the samecontrol device and/or on two distinct control devices. In this case, theprescriber interface will be able to be available on the control deviceof the prescriber (for example, a personal computer or another specificor non-specific device) and the patient interface will be able to beavailable on the control device of the patient. Furthermore, theparameterizing data (modified by the prescriber) will be saved by thetreatment system so that these data can be used by the control device ofthe patient.

Preferentially, the control device of the patient can display the twointerfaces so that the prescriber can modify data via the control deviceof the patient.

It may be possible to envisage having three distinct interfaces, forexample when the patient has reduced capabilities. The first interfacewould be accessible to the doctor, the second interface might beaccessible to a responsible person (a parent, a tutor, a pharmacist, anurse, other responsible personnel) and a third interface would beaccessible by the patient. A responsible person is a person having thecapacity, the knowledge and/or the competences necessary to receivespecific access rights. These access rights are lower than the accessrights of the prescriber but higher than the access rights of a patientwho would not be capable or sufficiently competent. This intermediateinterface is additional and optional, it depends primarily on thepatient treated. The prescriber could have access to all threeinterfaces, the responsible person could have access to two interfaces(his or her own and that of the patient) while the patient would haveaccess only to a single limited interface. This kind of hierarchy isfound for example when the patient is a child or a handicapped person.

Generally, some interfaces could be accessible via an access code knownonly to or in the possession of the prescriber (a doctor) or aresponsible person. Using the prescriber interface, for examplefollowing an assessment, the prescriber can edit various parameters ofthe treatment in order to match the needs and capacities of the patient.Thus, the prescriber can pre-enter data (such as, for example, a basalprofile or a predetermined quantity for a bolus) and the patientinterface makes it possible to select these pre-entered data (to selecta basal profile or to control a bolus infusion for example).Preferentially, the patient interface allows the patient to marginallyadjust the pre-entered data (for example to increase or reduce the bolusquantity to be infused).

In one embodiment, the prescriber interface makes it also possible toparameterize a user interface. Thus, the prescriber can personalize auser interface (for example the patient interface) guaranteeing anappropriate use and treatment. In other words, the prescriber couldactivate certain options allowing another user to have access to certainfunctionalities, such as the adjustment of the treatment.

According to a second aspect of the invention, the control device issuitable for proposing an interface that is intuitive and easy to useallowing a user to easily control the delivery device and optionally beable to marginally adjust the treatment.

Some treatments need to be adapted according to the lifestyle of thepatient, in other words according to his or her activity. “Activity ofthe patient” should be understood to mean the action carried out by thepatient during a period. This period can be the present, a recent pastor new future to the present or at least a period during which theeffect of the activity on the patient (for example his or her bloodglucose) must be taken into account. It can be a temporary physicalactivity, the taking of a meal, a temporary rest, an activity during aday or several days. For example, in the case of diabetes, a patientdoes not have the same needs for insulin throughout the day, oraccording to his or her activity or his or her state of health. Ineffect, the blood glucose of a patient fluctuates, for example, theblood glucose will be dependent on the type of meal and the quantity offood ingested. When the patient is sick or if he or she is currentlyperforming a physical effort, his or her insulin needs to regulate hisor her blood glucose will be substantially different. Thus, for patientswho are less regular or who have a poor knowledge of their needs, it isoften very difficult for them to follow their treatment. All the more sowhen, in the case of treatment for diabetes, the patient may need basaland bolus injections that are difficult to calculate.

Throughout the description of the present document, the term basal iscommonly used to describe the basic flow rate infused to a patient overa long duration, for example a day. The basic flow rate can be variableover time because the insulin needs differ throughout the day and dependalso on the sensitivity of the patient to the insulin which also variesover time. The basal is often contrasted with the bolus which is adelivery of a determined quantity over a relatively short durationcompared to the basal, for example a few seconds or minutes.

Thus, the control device includes a graphical interface suited to thepatient, this control device comprises a set of commands illustrated ona first screen. This set of commands is preset so that the patient nowonly has to activate or select a command for it to be executed withoutbeing constrained to enter an entire series of data in order to controlthe delivery device. For example, the devices of the prior art requirethe patient to complete several fields (e.g. carbohydrates ingestedduring the meal, type of food (red meat, bread, salmon, etc), thequantity in grams ingested, delivery flow rate, time of delivery,sensitivity to the medicine as a function of the time of delivery, etc)in order to control the delivery of the fluid. Now, according to thesecond aspect of the invention, the control device avoids theseconstraints and greatly simplifies the life of the patient.

Optionally, this set of commands can be adjusted by the patientmarginally. This adjustment can be done by predetermined increment.Preferentially, the prescriber will have previously parameterized thecontrol device so that the treatment is matched to the patient and thepossible adjustments will be limited according to rules established by adoctor and/or a qualified person (carer, responsible person, etc).

This aspect of the invention makes it possible in particular to:

-   -   limit the number of errors in the commands performed by the        patient;    -   simplify the use of the control system;    -   speed up the takeover by the patient.

Optionally, the system saves the history of the actions (measurement,bolus control and/or quantity delivered) so as to limit or prohibit anadditional command which could be damaging to the health of the patient.

In one embodiment, the patient can request the execution of a bolusdelivery command before or after or during a meal. The patient actuatesthis command by simply pressing on the type of meal (breakfast, lunch,dinner, supper, snack, etc) that he or she has ingested. Previously, thedoctor (prescriber) will have entered a set of typical boluses whichdepends on the type of meal or time of the meal or on the bolus commandand not dependent on the type of food ingested. The difference lies inthe fact that the patient has a limited choice (breakfast, lunch,dinner) unlike the other known systems which request information whichis often not understood by the patient (quantity of carbohydrate) orthat is difficult to estimate or recognize (weight of the food, type offood, etc). This is thus a major advance for the patient which, throughits simplicity, prompts him or her to use his or her control device.Depending on the needs and the capacities of the user, it may beadvantageous to also propose a bolus command simply by entering thequantity to be injected.

It may also be useful for the system to automatically recognize (basedon the time and/or the meal previously counted), whether it is abreakfast, a lunch or a dinner, thus simplifying the control steps whilereducing the risk of errors. Thus, the type of meal could be suggestedby the system, the patient optionally being able to accept the type ofmeal proposed or change it.

In other words, according to one embodiment, the control device issuitable for proposing a bolus command as a function of the type of mealthat the patient should or would have ingested. For example, when thepatient commands a bolus when he should be ingesting a breakfast (i.e.at the usual times at which a breakfast is traditionally taken), thecontrol device will propose a quantity of insulin which will be adaptedto meet the needs linked to a breakfast. This type of meal can beinformed by the user (as prescribed above) or determined or proposed bythe control device according to the time of day (for example accordingto a time band or preceding meal). Thus, the control device could besuitable for proposing a delivery command according to the time of theday when the patient commands this delivery.

Optionally, the control device stores the meals or the meal typesingested using a memory connected to the processor of the controldevice. Thus, upon the next bolus command, the delivery device will beable to compose a bolus suited to the next meal. For example, if thepatient ate at 6:00 am then at 11:30 am, the control device will be ableto propose a first bolus suited to a breakfast and a second bolus suitedto a lunch. Thus, the device is suitable for proposing a certainquantity of insulin according to a time band and/or according to themeal previously ingested.

The system can also make it possible to remind the patient that a bolusmust be administered if a delay is exceeded since the last bolus.According to one embodiment, the control device can prompt a patient toorder a bolus when a time band corresponding to a meal has passedwithout the patient having ordered bolus delivery.

According to one embodiment, in order to propose an easy adjustment of abolus command, the present invention can replace the calculation of thecarbohydrates by a simplified concept of increment according to the sizeof the portion of food eaten relative to a reference plateau. Thepatient can simply adapt his or her bolus by indicating whether he orshe is eating “a little more”, “much more”, “a little less” or “muchless”, modifying the initial bolus according to increments that havebeen pre-edited, for example by a doctor (prescriber). The increment cantake account of the sensitivity of the patient to insulin according tothe time of day (for example: time of day, a day can comprise up to 24hours).

According to one embodiment, the basal can be modified (temporarily ornot) by the user simply by selecting a profile or by entering his or herstate (sick, etc). Preferentially, the prescriber will first haveentered a set of data that the user will be able to use simply byactuating this control. Also, a control device can comprise a prescriberinterface, for example as described in the first aspect of theinvention. The prescriber interface makes it possible to define/edit oneor more basal profiles while the patient interface makes it possible toselect the appropriate basal profile.

In the present document, a basal profile is a succession of flow rateswhich will be executed over time (a day for example) by the deliverydevice. This succession of flow rates can be a succession of constant orvariable flow rates. Each flow rate depends on the need of the patientat a time T and defined by a prescriber. In other words, the prescriberdefines (preprograms) different basal profiles that the patient selectsand actuates according to the type of day (working day, weekend, etc)and/or his or her physiological state (sick, etc). The patient interfacethus comprises a set of commands preprogrammed by a prescriber and thatcan be actuated by the patient. Thus, the patient is not forced toestimate his or her treatment needs for the day but he or she simply hasto inform the system as to the type of day (holiday, working, sick, etc)to come or in progress.

According to one embodiment, the patient will be able to have access tooptions for temporarily adjusting his or her treatment, for example totake account of an activity performed temporarily by the patient. It canbe a sporting activity or at least an activity which would cause his orher blood glucose to decrease (substantially or not). Also, if thesystem did not take account of this lowering of blood glucose caused bythe activity of the patient, the patient would risk entering intohyperglycemia. This is why a patient must reduce or stop the delivery ofinsulin during such an activity. Now, an unaccustomed patient cannotestimate the reduction of his or her insulin needs because, to do this,he or she would have to perform complex calculations. Thus, the systemmakes it possible to reduce the delivery of insulin not according to anundesirable quantity of insulin but according to a concept that is morefamiliar and intuitive for the patient, such as the intensity of theactivity and/or the duration of the activity.

This differentiation is vital because, for an unaccustomed patient,reducing the delivery of insulin by 20% or by 50% is not representative.However, it is easier and more intuitive to inform of the intensity ofthe physical activity and/or its duration. In other words, the patientis no longer forced to estimate his or her reduced insulin need but heor she must simply inform the control device of his or her effort (forexample the intensity and/or the duration of the activity).Preferentially, the reduction of delivery of insulin will beproportional to the effort and parameterizable via a prescriber.

In other words, by virtue of the informing of an event undergone and/orperformed by the patient, the treatment system will perform an actionbeneficial to the treatment of the patient.

According to a third aspect of the invention, the control systemcomprises an interface that is simplified and organized so that thepatient quickly and intuitively recognizes the commands.

In one embodiment, the graphical interface comprises a succession ofscreens, at least two of which substantially identically illustrating aset of commands. In other words, at least two screens comprise at leasttwo distinct commands, said distinct commands of the first screen havingsimilar graphical characteristics (color and/or form) to the commands ofthe second screen. For example, a first screen and a second screenpresent four commands that can be actuated by the user and eachrepresenting a part of a disk (for example a quarter disk).

The graphic illustrations of the commands presented above can havedistinctive signs making it possible for the patient to easily, rapidlyand unequivocally identify the type of command, such as, for example, acolor code, a logo, a pictogram, a text, a form and/or a zone dedicatedto the type of command, etc.

According to a fourth aspect of the invention, the command can havecommunication means making it possible to transmit certain data (actionof the patient, actual delivery, blood glucose measurement) and tocheck, remotely, the compliance (observance or correspondence) of thepatient to the treatment. It can, for example, concern means forchecking, by a doctor or a nurse, elements of the treatment and/ormessages received in case of poor compliance of the patient to thetreatment (for example bolus or blood glucose measurement not performedor forgotten). This is in order to be able to remind the patient andindicate to him or her the procedures to be followed before the effectsof the poor compliance have repercussions on the state of health of thepatient.

In this document, the term compliance is defined as the behavior whichconsists in correctly following the prescriptions for use of themedicines.

The different embodiments presented in this document can be combined inorder to obtain all or some of the advantages of these embodiments.

LIST OF THE FIGURES

To allow for a better understanding of the invention, one or moreembodiments will be described, illustrated by the figures attached tothis document. It goes without saying that the invention is not limitedto these embodiments.

FIG. 1 schematically represents the user parameters that the prescribercan edit;

FIG. 2 illustrates an example of parameterizing;

FIG. 3 discloses possible display screens for the user;

FIG. 4 explains the different command instruction modification paths viathe user interface.

FIG. 5 schematically illustrates a treatment system comprising a controldevice and a medical device.

FIGS. 6 to 13 explain examples of a screen displayed by a controldevice.

LIST OF ELEMENTS

-   1 Treatment system-   2 Control device-   3 Delivery device-   4 User/patient-   5 Processor-   6 Memory-   7 Communication means-   8 Input device-   9 Screen-   10 Processor (if necessary)-   11 Memory (if necessary)-   12 Communication means-   13 Tank (optional)-   14 Pumping mechanism (optional)

DETAILED DESCRIPTION OF THE INVENTION

In the present document, the detailed description of the inventioncomprises embodiments of devices, of systems and of methods given by wayof illustration. It is clearly understood that other embodiments can beenvisaged and can be provided without departing from the scope or thespirit of the invention. Consequently, the following detaileddescription should not be taken in a limited sense.

Unless otherwise indicated, the scientific and technical terms used inthe present document have meanings commonly used by those skilled in theart. The definitions provided in this document are mentioned in order tosimplify the understanding of the terms frequently used and are notintended to limit the scope of the invention.

The verbs “have”, “comprise”, “include” or equivalent are used in thepresent document in a broad sense generally signifying “includes, butwithout being limited thereto”.

General Description of a Possible Embodiment

FIG. 5 discloses a medical treatment system (1) suitable foradministering a treatment to a patient (4). The treatment systemcomprises a control device (2) and a medical device which ispreferentially a delivery device (3). FIG. 5 schematically representsthe system with a control device (2) distinct from the delivery device(3). However, these two devices can be arranged in the same casing, notrepresented here. In the case where the two devices are not distinct,the system could comprise a single processor and/or a single memory. Inthis document, the memory can be of RAM, ROM, NVRAM, EEPROM or flashtype or any other type of memory known to those skilled in the art.

The control device (2) comprises a processor (5) that can be connectedto a memory (6), communication means (7), an input device (8) and ascreen (9). The control device can be a personal computer, a cell phone,a diabetes management system, a BGM, etc. It can be of a form that issmall enough to be held in the hand of the user and/or in his or herpocket. The memory (6) can further make it possible to save controlinstructions preprogrammed by the prescriber, the control instructionspreviously executed and/or the different actions, activities andinformation informed by a user.

The delivery device can comprise a processor (10) that can be connectedto a memory (11), communication means (12), optionally a tank (13) and apumping mechanism (14). Also, the delivery device can be adapted toinject into a patient (4) a fluid contained in the tank (13) using apumping mechanism (14).

A user (4) can be a prescriber, a patient or another person. The patientis the person who receives the medical treatment and interacts with thesystem whereas the other users are people who only interact with thesystem.

The system can comprise several control devices. For example, the systemcan comprise a control device reserved for the sole use of theprescriber and a specific control device for the patient. Ideally, thecontrol device of the patient is more easily transportable and is of asize small enough to be contained in a pocket. Its height can be between160 mm and 50 mm, its width between 90 mm and 30 mm and its depthbetween 5 mm and 30 mm, ideally it measures approximately 95 mm×60 mm×15mm to +/−5 mm. Preferentially, said control device of the patientcomprises at least two different graphical user interfaces, one that canbe accessed only by the prescriber and the other accessible to thepatient.

The patient interface can be the basic interface whereas the prescriberinterface is accessible only with a specific identification means. Abasic interface should be understood to be the interface which isaccessible directly or initially as soon as the control device isstarted up, switched on or awoken from standby. However, it is possible,upon first startup of the control device (that is to say before theprescriber has parameterized the control device in order to adapt it tothe patient), for the first interface to be that of the prescriber.However, after the parameterizing, the user interface will be able tobecome the basic interface.

The control device (2) and the delivery device (3) comprisecommunication means (7, 12) enabling them to exchange data by wired orwireless (radio wave, Bluetooth®, IR, wifi, etc) means. These data canbe, for example, an instruction sent by the control device to thedelivery device in order for the latter to execute a determined action(selection of a basal profile, injection of a bolus, reduction of thebasal profile, modification of the basal profile, etc). Thecommunication means (7, 12) can be adapted to transmit or exchange datawith another remote device, such as the computer of a prescriber or amedical server, etc. The communication can be performed by any meansknown to those skilled in the art, such as via an RJ45 port, USB, bywifi or GSM (3G or 4G). If there are several control devices, the lattercan also communicate with one another. For example, if the prescriberparameterizes or programs the system with a specific control device (forexample, a personal computer) then the control device of the prescriberwill be able to send the parameterizing data to the system, for exampledirectly to the control device of the patient.

The user (4) uses an interface to control the treatment system (1), thisinterface comprises a screen (9) and an input device (8). The interfaceis adapted to the user so as to offer options and functionalities thatare only necessary to, and understandable by, the user.

The input device (8) can be a button, a voice command, a glucosemeasurement means (BGM or a CGM), a keyboard, a mouse. The screen (9)and the input device (8) can form a touch screen.

Examples of an Intuitive Treatment System According to the Invention

One of the main benefits of the invention is that a prescriber has thepossibility of assigning a pre-established specific action to a key(input device (8)) in order for a user (for example the patient, whetheryoung or elderly) to be able to press on this key without worrying aboutthe program of the action which will be performed by the system.

In the context of the treatment for diabetes, the invention isparticularly suited to at least three types of instructions that apatient may be required to use regularly:

-   -   ordering a bolus during a meal, and/or    -   designating a basal profile, and/or    -   adjusting the basal profile according to the activity of the        patient.

Ordering a Bolus:

In order for the ordering of a bolus on the occasion of a meal to beusable by most diabetics (including type 2 diabetics), it is importantfor the use of this tool to be simplified and require only very littlethought on the part of the user.

Thus, the control device can comprise an input device that allows thepatient to enter not the quantity of insulin to be injected but the typeof meal which he or she has ingested or will ingest. The control devicethus presents at least one type of meal of the day (breakfast, lunch,dinner, etc). The patient (or other user) selects the corresponding typeof meal in order to obtain the appropriate treatment. Previously, theprescriber will have saved at least one standard treatment correspondingto a standard meal.

As presented in FIG. 3.2, the control device displays a patientinterface showing the different types of meal that the patient canselect. Optionally, the control device can offer/suggest a type of mealaccording to the meal previously informed and/or according to the timeof the day (in this case, the control device can comprise an internalclock).

This bolus preprogrammed by the prescriber can be adjusted according toseveral options:

-   -   by taking into account the blood glucose of the patient, and/or    -   by adjustment according to the quantity ingested.

Taking into Account the Blood Glucose of the Patient

If the patient has measured his or her blood glucose, the system will beable to offer a correction making it possible to adjust the bolusaccording to the blood glucose (of the patient) measured previously.FIG. 3.3 shows the patient interface with a correction of the boluslinked to the measured blood glucose of the patient. It concerns inparticular the information displayed to the right of the iconillustrating a droplet also including the annotation BGM. The patientwill optionally be able to accept or not accept this correction, forexample by pressing on the corresponding key or icon (in this document,the terms icon, logo or pictogram are used interchangeably). Thiscorrection can take effect if the blood glucose measurement has beenperformed within a certain time period preceding the present boluscommand. If this time period is exceeded, then the control device willbe able to prompt the patient to perform a new blood glucosemeasurement, for example by pressing on the corresponding key, pictogramor icon. Furthermore, the input device (8) of the control device can beused to inform of the blood glucose of the patient. It can be a simplekeyboard (on which the patient enters the measurement performed withanother device) or a blood glucose measurement means (BGM, CGM) notrepresented in the figures.

Adjustment According to the Quantity Ingested

Still with the aim of simplifying the use of the treatment system (1) bythe patient, the invention proposes that the patient only has toestimate if he or she is eating as usual, more or less than usual ormuch more/much less than usual. This estimation of the quantity ingestedof the type of meal makes it possible for the system to adjust thequantity of insulin to be injected.

Once again, the input device (8) makes it possible to inform the controldevice of the quantity ingested. The control device can graphicallyillustrate this option using + or − signs but also by using iconsrepresenting a certain meal quantity as disclosed in FIG. 4. FIG. 3.4illustrates the graphical interface of the patient. The icons in cupform represent the type of meal (here a breakfast), and it will also benoted that it is a graphic representation substantially identical tothat of FIG. 3.2 that the patient has selected (highlighting of theselected icon).

FIG. 3.2 represents the patient graphical interface. The breakfast iconis highlighted and the others are grayed out. This highlighting of anicon can reflect the fact that the patient has selected this icon or canbe a proposal from the control device. In the latter case, the patientwill simply have to validate this proposal or select another type ofmeal.

According to one embodiment, the patient now only has to touch thesmallest or largest cup to inform of the quantity ingested in thebreakfast. For information, the graphical interface also presents theadjusted quantity of insulin. Thus, the patient can check that thisvalue is indeed consistent. That makes it possible to reassure thepatient, inform as to the quantity calculated but also make the patientaware of the quantity of insulin necessary. Thus, the patient learns hisor her insulin needs through practice, making it possible for him orher, in case of failure of his or her system, to approximately assesshis or her insulin needs.

Preferentially, the patient can enter this information according to theincrementation prescriptions previously programmed by the prescriber. Inother words, the prescriber will be able to previously parameterize theincrements increasing or reducing the quantity of insulin. Theseincrements are used when the patient adjusts the quantity of mealingested.

This approach requires little involvement on the part of the patient whocan correct his or her bolus according to the size of his or her meal in3-4 presses with no carbohydrate calculation requirement. Thisimage-based approach makes this tool accessible to all (children,elderly people, patients with cognitive deficiencies, etc).

FIG. 4 shows a flow diagram which illustrates a succession of screens ofthe patient interface when he or she informs the control device of thequantity of meal ingested.

In reality, through the patient interface, the latter does not order aninjection but informs the system of an event (of an action performed orwhich will be performed by the patient) which is, here, the taking of ameal. The aim of the system is thus to adapt the therapy according toinformation given by the patient. In other words, the processor uses amathematical model adapted by the prescriber (incrementation, degree ofsensitivity to insulin, etc) which takes into account the type of mealingested by the patient. The mathematical model can also take intoaccount the quantity ingested and/or a measurement of blood glucose ofthe patient.

Designation of a Basal Profile

In the prior art devices, the patient creates, with the help of adoctor, a profile of flow rates which will be infused throughout theday. This is the basal profile. Normally, the patient has thepossibility of modifying the basal profile but this is very complicatedand can lead to a substantial modification of the treatment. Also, thisaction can be relatively dangerous for the patient. An unaccustomedperson will not have sufficient competences to modify this basal profilefor all the treatment has to be able to be adapted according to the daybecause the insulin needs can vary according to different parameters.Some devices make it possible to save several basal profiles but it isnot obvious to an uninitiated person how to recognize the profile whichis suited to a given day.

To eliminate this drawback, the invention proposes to easily andcomprehensively presenting at least two basal profiles. Thus, thecontrol device makes it possible to identify each profile according to atypical day or a physiological state of the patient.

Each typical day represents the usual activity of the patient duringthat typical day (for example: working type day, typical day when thepatient is on holiday or sick, etc). In other words, as illustrated byFIG. 3.9, the patient interface presents the basal profiles according toat least two typical days (for example, on this screen, it is possibleto distinguish two typical days: a working week or weekend) and/oraccording to the state of health of the patient (for example, on thisscreen, it is possible to select the typical day: sick). The screen 3.10makes it possible to inform the patient of the exact profile (that is tosay the basal rate profile) before the latter validates this option.

In the case where the system comprises an internal clock, the device cansuggest a basal profile. For example in FIG. 3.9, the first icon ishighlighted and the others are grayed out; that can be due to the factthat the patient has selected this icon but that can also be asuggestion on the part of the control device. Thus, depending on the dayof the week for example, the device may suggest a typical day that thepatient will be able to validate or not as for the type of mealdescribed above.

Thus, the patient does not select a basal profile but informs thecontrol device as to the current type of day and/or his or her state ofhealth. Previously, a prescriber will have parameterized or programmedat least one typical day corresponding to a basal profile adapted to thepatient according to this typical day.

Temporary Adjustment of the Basal Profile According to the TemporaryActivity of the Patient:

A basal adjustment option can be used over a relatively short period.This involves adjustment according to the temporary physical activity ofthe patient.

Thus, the control device presents, via its patient interface, anadjustment option allowing the patient to inform of his or her temporaryphysical activity via the input device. The temporary physical activityis an activity performed (or which will be performed) by the patient fora limited duration (for example: a few minutes to a few hours butstrictly less than 24 hours). It can be sport, a stroll or any otherunusual physical activity on the part of the patient which would causehis or her blood glucose to lower. The input device can further make itpossible to inform of the amplitude of the effort such as, for example,the intensity and/or the duration of this activity. The simple fact ofactuating this option will lead to a modification of the infusion (inthis particular case, a reduction of the insulin infusion).

In order to allow this functionality, the control device comprises aninput device allowing a user (for example a patient) to inform of thetemporary effort of the patient so that the system temporarily adaptsthe treatment according to these data. The control device thus presentsan “activity” option which, upon the activation thereof, allows thepatient interface to display at least one screen prompting the patientto assess intensity of the physical activity and/or the duration of thisactivity. An illustration of these screens is presented by FIGS. 3.6 and3.7. FIG. 3.8 presents a summary prior to validation of the adjustment;it makes it possible to inform the patient of the instruction which willbe sent to the delivery device.

Preferentially, the control device proposes at least two intensitylevels. The prescriber will have previously predetermined the impact ofthis activity according to the intensity level and/or the duration. Theprocessor can also comprise a mathematical model making it possible toachieve the same end. In other words, the system can make it possible tocalculate an adjustment of the treatment according to the intensityand/or the duration of the physical activity.

To sum up, the patient is no longer concerned with the programming, butinforms the control device of his or her activity (eating, sick, type ofday, physical activity) provoking a reaction preprogrammed by theprescriber.

Examples of Use of the Prescriber Interface

Initialization

In one embodiment, upon first use of the interface, an administrator (orprescriber) code, previously given to the treating doctor (orprescriber), is requested in order to establish the first userparameters which are listed in FIG. 1.

Example of Parameterizing

Each of these parameters can be personalized by the treating doctor(prescriber) according to the needs of the patient (for example in FIG.2) and the parameterizing of these options will define the finalinterface obtained (for example in FIG. 3). While the patient canrequest the execution of the control instructions, it is impossible forhim or her to parameterize said control instructions, that is theexclusive role of the prescriber. In the following example, the specificparameterizing chosen will define the interface that the user will beable to manipulate without being able to edit it.

To access the parameterizing, the user must specify what type of user heor she is, for example like the left-hand image of FIG. 7. In thisimage, the system can comprise at least two different types of users(patient, caregiver, health care professional) and thus with differentaccess rights. Preferentially, the patient will not be able to accessany parameterizing option. In one embodiment, if the patient hassufficient knowledge, the prescriber will be able to choose to give himor her access to certain parameterizing. After the selection of the typeof user, the latter must enter his or her personal code (for example aPIN code) then a parameterizing screen will be displayed (right-handimage of FIG. 7). FIG. 7 thus describes the succession of screens toaccess the parameterizing of the system.

Modification of Parameters and Influence on the User Interface

The possibility of being able to activate or else deactivate most of theoptions will therefore have a great impact on the user interface. Takethe example of a patient who, according to the treating doctor, does notuse the “activity” option, he or she can deactivate it (set this optionto off) and thus influence the design of the user interface. Similarly,if a treating doctor estimates that this tool (pump and remote control)is suitable to treat a diabetic child only via the use of the “set”(basal) option, he or she can make the other options (bolus andactivity) inactive thus modifying the user interface. This aspect of“activation if there is a need” will make it possible to remove theunused options which could disturb the patient. This offers a greatadvantage because the doctor can then prescribe a pump treatment to aperson who has a cognitive deficiency without in any way running therisk of the latter using options which could be hazardous or even fatalto him or her.

Furthermore, the prescriber interface makes it possible to act on:

-   -   the activation of the bolus, basal and/or activity options (see        the middle of FIG. 1). In the case where these three actions        would be inactive then the control device would allow the        patient only to measure his or her blood glucose using an input        device (e.g.: a specific sensor) and/or to have access to the        actions history; and/or    -   the activation of the activity intensity levels (at least two,        for example: light, medium, intense) and/or duration options        (for example: 30 min, 1 hour, etc), an example of a graphical        interface is disclosed in FIG. 8; and/or    -   the increments of the intensity and/or of the duration; and/or    -   at least two (ideally four: for example: weekend, week,        holidays, sick) basal profiles of which the headings and the        data can be parameterized by the prescriber; and/or    -   at least two (ideally three and optionally the possibility of        doing a manual input) types of meal: their heading and the        respective quantities of insulin; and/or    -   the increments of the bolus option (whether for the manual        option or for the adjustment of the quantity)    -   the activation of the taking into account of a blood glucose        measurement and/or the duration of validity of this measurement;        and/or    -   the blood glucose measurement options.

Ultimately, the invention offers the user an interface which can bemodulated by an administrator (who is the prescriber for example)according to his or her needs and his or her capacities. This thereforeopens use of the insulin pump to a very wide population.

Example of Overall Parameterizing

FIG. 2 illustrates the final parameterizing performed by a prescriber.Also, the control device will enable the patient for example to reduceby 25% the quantity of insulin for 30 minutes during an activity, or toorder a dose of 14 units during a lunch and to uprate it by 2.5 units ifthe lunch is relatively large.

Example of Parameterizing by the Treating Doctor for the Bolus Options

Using this simplified bolus command, the system is programmed in advanceby a prescriber via a specific interface allowing the prescriber to savethe necessary treatment adapted to the patient according to the type ofmeal that he or she will come to ingest in a day.

The incrementation parameters according to the estimated quantity offood are previously edited by the treating doctor (prescriber). Forexample:

Meal “I eat “I eat “I eat “I eat much less” less” more” much more” Boluscorrection −5.0 [U] −2.5 [U] +2.5 [U] +5.0 [U]

Examples of Patient Interfaces

FIGS. 3.1 to 3.10 show a set of screens that can follow one another andwhich are used by the patient graphical interface.

FIG. 3.1 shows a screen which can be the basic screen, that is to saythe main screen which is displayed when the control device is switchedon or woken up from standby. A first top strip can provide informationto the user as to the time and the status of the elements of the device(for example the reception level, the battery level, etc). A secondspecific zone makes it possible for the user to know the last mealinformed and, optionally, the quantity of insulin injected by thedelivery device. If no correction or adjustment has been made by theuser then it is also the quantity of insulin associated with this typeof meal. Most of the screen is devoted to the main command options.These commands allow the user to inform the system regarding:

-   -   the blood glucose measurement. Using this command, the patient        will be able to inform the control device of his or her blood        glucose level at a given moment. This information is informed        using an input device which can be a set of keys, a keyboard, a        specific sensor (those used for example by the BGMs or the CGMs        known to those skilled in the art). In the latter case, when the        patient has selected this command, the graphical interface will        display a succession of screens comprising fixed and/or animated        images with a text explaining the procedure to be followed. The        patient will also be able to specify whether the blood glucose        measurement was performed before or after a meal. All of this        information will then be saved in the memory of the control        device so that the user can review a measurement and/or the        doctor can also track the curve of the blood glucose of his or        her patient. This information can also be sent to a dedicated        medical server for the patient to be tracked as accurately as        possible; and/or    -   the taking of a meal; and/or    -   the temporary physical activity of the patient; and/or    -   the current type of day.

According to one embodiment, these four commands are arranged in fourdisk quarters (or arcs of a circle). Each command is represented by aquarter disk in which there can be a graphical illustration, informationand/or text. Each command can have a specific color. For example, theblood glucose measurement can have an icon (quarter disk) with a greenbackground color, the meal in yellow, the activity in blue and the typeof day in violet.

Access to the History Option

At the center of this command disk (or arc of a circle) of the basicscreen there is, according to FIG. 3.1, a circle with a characterrepresenting an “i”. This circle (or icon, or pictogram) makes itpossible to access a command displaying the history. As soon as thiscommand is selected, a new screen can be displayed representing in asubstantially identical manner the preceding graphical interface, moreparticularly, the four icons of the main commands (the quarter disks ofthe previous commands). In other words, the basic screen presents thefour icons of the main commands (blood glucose, meal, activity, type ofday) and a “history” command which makes it possible to display a newscreen comprising the same icons as those of the main commands. Thesenew icons make it possible to access the history of each main command.

An illustration of this succession of screens is disclosed by FIG. 6.This figure shows three screens which follow one another, the first isthe main (or basic) screen, the second is the history screen showing thesame icons as the preceding screen and the third screen displays thehistory of the meal command (after selection of the meal command in thehistory). This screen lists the different types of meals taken, the timeand date they were informed and the quantity of insulin injected.

At the center of the “history” screen there can be another icon such as,for example, a “return” command or an “alarm” command which willdisplay, if the user selects this command, the history of the alarms.

The patient graphical interface also allows other successions of screenscomprising icons having similar graphic characteristics between a firstscreen and a second screen. For example:

-   -   if the user selects the “meal” command of the basic screen (FIG.        3.1) then a second screen (FIG. 3.2) will be able to be        displayed presenting icons having the same form as the icons of        the commands of the basic screen. That is to say, here, four        quarter disks.    -   If the user selects the “activity” command of the basic screen        (FIG. 3.1) then a second screen and optionally a third screen        (FIGS. 3.6 and 3.7) will be able to be displayed showing icons        having the same form as the icons of the commands of the basic        screen. That is to say, here, four quarter disks.    -   If the user selects the “type of day” command of the basic        screen (FIG. 3.1) then a second screen (FIG. 3.9) will be able        to be displayed showing icons having the same form as the icons        of the commands of the basic screen. That is to say, here, four        quarter disks.

The color code of the main command can be used as a distinctive sign ofthe commands. Thus, the background color of the icon (for exampleyellow) can be used by the other icons of the second screen or displayedin a specific zone such that the user recognizes the command previouslyselected. In other words, at least one distinctive sign of the commandselected in the first screen is illustrated unequivocally by the secondscreen.

At the end of each command, the control device can display a summaryscreen and/or request a confirmation code (PIN code for example).

Other Examples of Interfaces

The system is particularly suited to type 2 diabetics because itrequires only little knowledge of the disease on the part of the patientand also by virtue of its ease of use. However, it may be advantageousto use this system for a type 1 diabetic, particularly when the user(for example the patient or a parent of the patient) is in a phase oflearning how to treat his or her disease. Thus, the system can evolvewith the patient. In a first stage, the system will propose only verybasic functionalities then the prescriber will be able to add (orremove) over time (after several weeks, months and years, or accordingto the age of the patient) other functionalities. The functionalitiespresented hereinbelow may also be available only to a responsible person(that is to say not accessible to the patient but, for example, to acaregiver or a parent).

In FIG. 9.1, this functionality allows a more experienced user tocontrol different types of bolus (single, extended or dual).

In FIGS. 9.1 and 9.2, the screen proposes additional information inaddition to three possible control instructions. This additionalinformation can be the last blood glucose measurement of the patient, itcould also be the last bolus command or the need (or the prompting) toperform a new measurement of the blood glucose (for example if the lastmeasurement is too old).

In FIG. 9.3, the screen allows the user to activate or deactivate thecorrection(s) proposed by the control device according to the last bloodglucose measurement and/or according to the remaining quantity ofinsulin active in the body of the patient, that is to say the insulinwhich has been injected into the patient and which will (in the nearfuture) have an action on the blood glucose of the patient. On thisscreen, the patient has ordered a quantity of 10 U of insulin, thedevice proposes adding 5.5 U thereof to correct the blood glucose and toremove 3.5 U therefrom to take account of the quantity of insulin stillpresent in his or her body.

In FIG. 10, the device allows the user to order a dual bolus. This isthe infusion of a bolus in two successive steps. Firstly, the deliverydevice will inject a first quantity of insulin during a first period,then, during a second period, the device will inject a second quantityof insulin. The control device thus proposes a succession of screensmaking it possible to control a dual bolus. In a first screen, the userselects the “dual bolus” control instruction then another screen allowsthe user to decide on the distribution of the quantity of insulin to beinjected during the first and second periods. This can be a distributionbar whereby the user can define this distribution by moving it to theright or to the left. The screen can inform the user of thisdistribution either in units or as a percentage per period, thecalculation can be performed automatically when the user moves thedistribution bar. Another screen allows the user to define at least theduration of the second period. A last screen summarizes all of thiscontrol instruction in particular the total quantity of insulin orderedfor this control instruction.

FIGS. 11 and 12 show how a user can be guided during a procedure. Forexample, FIG. 11 presents a succession of screens explaining to the userthe steps necessary to perform a blood glucose measurement using a BGM.This BGM can be a function of the control device. FIG. 12 explains howto fill a tank of the delivery device. These screens may contain text,numerals, symbols, fixed and/or moving graphical illustrations, a video.Sound information can also provide more comprehensive information ororally describe the procedure. This is a genuine advantage forunaccustomed people and that makes it possible to teach the user theprocedure to be carried out.

The images of FIG. 13 present screens comprising additional informationon the screen. In one embodiment, this is a box that is checked or notchecked (or unchecked). For example:

-   -   if the box alongside the blood glucose input command (“CHECK”)        is checked that can mean that the last blood glucose measurement        has been performed, measured or input within a certain time        period. Also, this measurement may even be valid and may be used        for the correction in the case of a bolus command.    -   If the box alongside the basal command (“SET”) is checked, that        can mean that a basal profile or that a basic rate is currently        being delivered. If it is unchecked, no basal injection is        performed by the delivery device.    -   If the box alongside the bolus command (“EAT”) is checked, that        can mean that the delivery device is currently delivering a        recently ordered bolus. This may also mean that:        -   insulin still active is present in the body of the patient,            this box would therefore be a function of a mathematical            model which calculates the IOB (Insulin on Board) over time            due to a bolus injection.        -   The patient can now order a bolus. Thus, a prescriber will            have previously designated time bands during which the            patient or other user can order a bolus command. This            activation of the bolus command can also be illustrated by a            colored key which is grayed out when the command is            deactivated.    -   If the box alongside the activity command (“MOVE”) is checked,        that can mean that the system takes account of the fact that the        patient at this moment performs a temporary physical activity.

It will also be noted that the headings of the commands have no medicalconnotation, so the control device does not remind the patient that heor she is sick, the patient lives better with his or her sickness and isthus more cooperative. In other words, the control device does notreturn a negative and restrictive image of the medical treatment, itsimply allows the user to enter data which are linked to the activity ofthe patient (taking of a meal, lifestyle, physical activity, etc).

The system is adapted to increase the awareness of or train a user tolive better with a sickness such as diabetes. In effect, using its basicscreen, the patient instantaneously sees the four correct modes ofconduct:

-   -   regularly measure the blood glucose of the patient    -   order a bolus to offset the input of carbohydrates in a meal    -   adapt his or her basal profile to his or her lifestyle    -   reduce his or her insulin input during a physical activity. The        activity key also makes it possible to prompt a patient to        perform a physical activity that is temporary but to do so        regularly.

The system thus comprises a teaching function. Furthermore, the systemcan comprise a reminder system for reminding the patient to inform thesystem of the taking of a meal or not, the measurement of blood glucose,etc. The succession of screens and in particular that of the boluscommand can allow the user to learn to estimate his or her insulin needsaccording to the type of meal and, optionally, the relative quantity(relative to the quantity of a standard meal of the patient) ingestedduring this meal.

Examples of Embodiments and of Use

The invention describes a control interface for controlling a medicaltreatment system which comprises preprogrammed control instructions. Thecontrol interface comprises:

-   -   a display device,    -   an input device for receiving at least one user input,    -   a processor configured to process control instructions.

The input device is suitable for receiving a datum linked to theactivity of the patient and informing the system of this datum. Theprocessor is suitable for suggesting, through the display device, acontrol instruction that can take into account one or more preprogrammedcontrol instructions, the activity of the patient and/or at least oneother datum input by the user or determined by the system.

Another datum input by the user can be: a type of meal, the quantity ofsaid meal, a level of effort linked to a physical activity, a durationof physical activity performed by the patient, a state of health, ablood glucose measurement, a day of the week, a time, a period or a typeof day. Another datum determined by the system can be: a type of meal,data measured by a sensor suitable for recording the movements of thepatient, a duration of physical activity performed by the patient, astate of health, a blood glucose measurement, a day of the week, a time,a period or a type of day.

According to one embodiment, the activity of the patient is the takingof a meal. Furthermore, the input device is suitable for informing ofthe type of meal and/or a quantity ingested by the patient. The type ofmeal can be a breakfast, a lunch or a dinner. A quantity ingested by thepatient can be a relative quantity in relation to the quantity usuallyingested by the patient. The interface can be adapted to suggest a typeof meal according to a time band and/or the meal previously entered. Inother words, the processor can take account of these data.

According to one embodiment, the activity of the patient is a temporaryphysical activity. Furthermore, the input device can be adapted toinform of the level of effort and/or the duration of the temporaryactivity performed by the patient.

According to one embodiment, the activity of the patient is the usualactivity of the patient during a typical day. Furthermore, the inputdevice can be adapted to inform of the current type of day of thepatient.

The control instructions can be dependent on the date and/or the time ofthe current day. The control interface can be adapted to suggest acontrol instruction taking into account at least one control instructionpreviously executed. A communication means can make it possible to senddata to a remote device in case of a compliance fault.

The processor can be adapted to send a reminder automatically to theuser when the user has omitted to send a control instruction. Thedisplay device can be adapted to display a main menu allowing access tothe main control instructions from a single screen. The input device canbe adapted to receive at least one input from a prescriber allowing theparameterizing of at least one control instruction. The patient cannothave access to the parameterizing of the control instructions. The inputdevice can be adapted to adjust the control instructions according to atleast one given increment. This increment can be parameterized by theprescriber. The bolus increment can be a function of the time before orafter the presumed time of delivery (i.e. meal) or of a sensitivityfunction of the patient according to the time of day.

The invention also describes a system for controlling the administrationof a fluid to a patient, this system comprises:

-   -   a fluid administration device configured to deliver a fluid to a        patient,    -   a control device designed to send delivery commands to the        administration device.

The control device preferentially comprises input means and a displaydevice suitable for offering together two distinct interfaces:

-   -   a prescriber interface, and    -   a patient interface.

The prescriber interface is designed to edit a delivery command suitedto a given patient and to parameterize input means of the user interfacewhereas the patient interface is designed to send a delivery command tothe administration device and/or to adjust a delivery command accordingto the activity of the patient and/or at least one other datum input bythe patient or determined by the system. Some input means may only beable to be used via the prescriber interface. The input means of theuser interface may be represented by virtual or physical buttonscomprising icons, pictograms or specific symbols. Input means of thepatient interface can be designed to increase or reduce the quantitydelivered by predetermined increment. The increments can be variable asa function of time and/or edited via the prescriber interface. Thepatient interface can be designed to suggest a delivery command as afunction of time and of data pre-parameterized via the prescriberinterface. Furthermore, at least one of the interfaces can be adapted tobe accessible only for the user of a password or via a specificunlocking means. For example, the prescriber interface cannot beaccessible to the patient. The adjustment of a delivery command can betemporary. A delivery command can be defined over a certain durationpre-parameterized via the prescriber interface. A delivery command canbe defined over a certain duration itself defined via the user interfaceby increments determined via the prescriber interface. A deliverycommand can be adjusted according to the suggestion of the controldevice following the input of a physiological datum of the patient. Aprocessor can be adapted to monitor the compliance of the treatment. Thesystem can further comprise communication means for exchanging data witha remote device, for example for monitoring the compliance of thetreatment. The system can comprise an internal clock suitable forinforming the system of the current date and/or time.

The invention also describes a method for controlling a medicinedelivery device using a control device comprising a display device, aninput device, a control interface, a processor. The method comprises thefollowing steps:

-   -   the establishment of control instruction suggestions taking into        account one or more preprogrammed control instructions, the        activity of the patient and/or at least one other datum input by        the user or determined by the control device;    -   the display of at least one suggestion on the display device;    -   the activation via the input device by the patient of at least        one suggested control instruction.

The method can further comprise at least one of the following additionalsteps:

-   -   modification of the control instruction by predefined        increments, said modification being able to be performed by the        patient;    -   modification of the control instructions preprogrammed by a        prescriber via the input device;    -   modification of the increments by a prescriber via the input        device.

The invention also describes a method for treating the diabetes of apatient using a treatment system which comprises a memory, an inputdevice, a display device all linked to a processor. The system can beadapted to execute at least one pre-parameterized control instruction,the method comprises the following steps:

-   -   informing the system as to the activity of the patient via the        input device;    -   suggesting a control instruction according to pre-parameterized        data, the activity of the patient and at least one other datum        input by the user or determined by the system;    -   validating the suggestion;    -   executing the control instruction.

The method can optionally comprise at least one of the following steps:

-   -   informing the system as to the type of meal ingested by the        patient;    -   informing the system as to the quantity ingested by the patient,        for example the relative quantity in relation to the quantity        usually ingested by the patient;    -   informing the system as to the level of effort of the temporary        activity performed by the patient;    -   informing the system as to the duration of the temporary        activity performed by the patient;    -   pre-parameterizing at least one control instruction and saving        it in the memory;    -   adjusting the control instruction;    -   adjusting the control instruction according to pre-parameterized        increment;    -   pre-parameterizing at least one increment;    -   receiving measurements of the blood glucose of the patient and        adjusting the control instruction according to the blood glucose        measurement.

The pre-parameterizing can be performed by a specific user. The patientcannot pre-parameterize the control instructions.

The invention also describes a learning method for a patient for his orher treatment for diabetes, said method being able to comprise thefollowing steps:

-   -   use of a control interface as described in one of the preceding        embodiments;    -   informing of the activity of the patient;    -   suggestion by the system and display of the control instruction        suited to the need of the patient according to pre-parameterized        data and the activity of the patient;    -   validation of the suggested control instruction.

The invention also describes a method for recommending a quantity ofinsulin to be injected before, during or after a meal, said method cancomprise the following steps:

-   -   use of a control interface as described in one of the preceding        embodiments;    -   informing of the type of meal ingested or which will be        ingested;    -   optionally, informing of the quantity ingested relative to the        quantity of a standard meal of the patient;    -   computation by the processor of the quantity of insulin suited        to the need of the patient according to the information given;    -   display of the recommended quantity of insulin.

The invention also describes a method for recommending the adjustment ofa quantity of insulin to be injected before, during or after a temporaryphysical activity performed by a patient, said method can comprise thefollowing steps:

-   -   use of a control interface as described in one of the preceding        embodiments;    -   informing of the level of effort of the patient during said        physical activity and/or of the duration of said physical        activity;    -   computation by the processor of the quantity of insulin suited        to the need of the patient according to the information given;    -   display of the recommended quantity of insulin.

The invention claimed is:
 1. A control interface device for controllinga fluid administration device and for suggesting an insulin dose for apatient via a graphical user interface, the control interface devicecomprising: a display device for displaying the graphical userinterface; an input device for receiving a plurality of inputs from auser of the control interface device; and a processor configured tocontrol the graphical user interface to display a first list ofelements, each element of the first list representing an activityperformed or to be performed by the patient, display a second list ofelements, each element of the second list representing a meal type takenor to be taken by the patient, graphically suggest a selection of anelement for the first and the second list depending on at least one of acurrent time, a current day, and a previous selection for the first andthe second list of elements, the input device receives a first userinput selecting the suggested selection, display a suggested controlinstruction for the patient, the suggested control instruction includingat least one of an insulin delivery flow rate, insulin deliveryquantity, and insulin delivery duration to be performed by the fluidadministration device, after the processor has determined the suggestedcontrol instruction for the patient based on (i) the received first userinput and (ii) control interface device control instructionspreprogrammed by a prescriber, display a validation command permitting avalidation of the suggested control instruction by the user, and acceptthe validation command by a second user input to validate the suggestedcontrol instruction, wherein the fluid administration device isconfigured to deliver the insulin dose to the patient according to thevalidated control instruction.
 2. The control interface device asclaimed in claim 1, wherein the processor is further configured tocontrol the graphical user interface to display a graphical elementpermitting a selection of an intensity level of the selected activity,and display a graphical element permitting a selection of a duration ofthe selected activity.
 3. The control interface device as claimed inclaim 1, wherein the processor is further configured to receive datafrom a sensor for recording movements of the patient, receive data on ablood glucose measurement, and display the data on the graphical userinterface.
 4. The control interface device as claimed in claim 1,wherein the processor is further configured to control the graphicaluser interface to display a graphical element allowing a selection of aquantity of the selected type of meal ingested by the patient.
 5. Thecontrol interface device as claimed in claim 4, wherein the quantityingested by the patient is a relative quantity in relation to a quantityusually ingested by the patient.
 6. The control interface device asclaimed in claim 1, wherein the activity of the patient is a temporaryphysical activity.
 7. The control interface as claimed in claim 6,wherein the processor is further configured to control the graphicaluser interface to display at least one of a level of effort and aduration of the temporary physical activity performed by the patient. 8.The control interface device as claimed in claim 1, wherein theprocessor is further configured to control the graphical user interfaceto display a command icon for increasing and decreasing a value of thesuggested control instruction by predefined increments whilesimultaneously displaying the suggested control instruction, and permitan adjustment of the suggested control instruction.
 9. The controlinterface device as claimed in claim 1, wherein the processor is furtherconfigured to control the graphical user interface to display a basalrate profile of the suggested control instruction while simultaneouslydisplaying the validation command.
 10. The control interface device asclaimed in claim 1, wherein the type of meal includes at least one of abreakfast, lunch, dinner, supper and snack.
 11. The control interfacedevice as claimed in claim 10, wherein the processor is furtherconfigured to control the graphical user interface to permit a selectionand graphically suggest a selection of an element of the second listdepending on the type of meal previously taken or selected by thepatient.
 12. The control interface device as claimed in claim 1, whereinthe graphically suggesting highlights one element of at least one of thefirst and second list of elements as the selection.
 13. A system forsuggesting an insulin dose for a patient via a graphical user interfaceand for delivering the insulin dose to the patient via a fluidadministration device, the system comprising: the fluid administrationdevice configured to deliver the insulin dose to the patient; and acontrol device configured to send a delivery command to the fluidadministration device, the control device including a processor, aninput device, and a display device, the processor configured to generatethe graphical user interface on the display device, the graphical userinterface configured to display a first list of elements, each elementof the first list representing an activity performed or to be performedby the patient, display a second list of elements, each element of thesecond list representing a meal type taken or to be taken by thepatient, graphically suggest a selection of an element for the first andthe second list depending on at least one of a current time, a currentday, and a previous selection for the first and the second list ofelements, the input device receives a first input from a user of thecontrol device selecting the suggested selection, display a suggesteddelivery command for the patient, the suggested delivery commandincluding at least one of an insulin delivery flow rate, insulindelivery quantity, and insulin delivery duration to be performed by thefluid administration device, after the processor has determined thesuggested delivery command for the patient based on (i) the receivedfirst input and (ii) control device delivery commands preprogrammed by aprescriber, display a validation command permitting a validation of thesuggested delivery command by the user, and accept the validationcommand by a second user input to validate the suggested deliverycommand, wherein the fluid administration device is configured todeliver the insulin dose to the patient according to the validateddelivery command.
 14. The system as claimed in claim 13, wherein thefirst and second list of elements are represented by virtual buttonsincluding at least one of icons, pictograms, and specific symbols. 15.The system as claimed in claim 13, wherein the processor is furtherconfigured to control the graphical user interface to display a commandicon for increasing and decreasing a value of the suggested deliverycommand by predefined increments while simultaneously displaying thesuggested delivery command, and permit an adjustment to the suggesteddelivery command.
 16. The system as claimed in claim 15, wherein thepredefined increments are variable as a function of time.
 17. The systemas claimed in claim 13, wherein the processor is further configured tocontrol the graphical user interface to display a basal rate profile ofthe suggested delivery command while simultaneously displaying thevalidation command.
 18. The system as claimed in claim 13, wherein thegraphical user interface is configured to suggest the suggested deliverycommand as a function of time and data pre-parameterized via aprescriber interface.
 19. The system as claimed in claim 18, wherein theprescriber interface is accessible only via at least one of a passwordand a specific unlocking device.
 20. The system as claimed in claim 13,wherein the type of meal includes at least one of a breakfast, lunch,dinner, supper and snack.
 21. The system as claimed in claim 20, whereinthe processor is further configured to control the graphical userinterface to permit a selection or graphically suggest a selection of anelement of the second list depending on the type of meal previouslytaken or selected by the patient.
 22. A method operated on a controlinterface device for controlling a fluid administration device todeliver an insulin dose to a patient, the control interface deviceincluding a display device, an input device, and a processor operating agraphical user interface, the method comprising the steps of: displayinga first list of elements, each element of the first list representing anactivity performed or to be performed by the patient; displaying asecond list of elements, each element of the second list representing ameal type taken or to be taken by the patient; graphically suggesting aselection of an element for the first and the second list depending onat least one of a current time, a current day, and a previous selectionfor the first and the second list of elements, the input devicereceiving a first input from a user of the control interface deviceselecting the suggested selection; displaying a suggested controlinstruction for the patient, the suggested control instruction includingat least one of an insulin delivery flow rate, insulin deliveryquantity, and insulin delivery duration to be performed by the fluidadministration device, after the processor has determined the suggestedcontrol instruction for the patient based on (i) the received firstinput and (ii) control interface device control instructionspreprogrammed by a prescriber; displaying a validation commandpermitting a validation of the suggested control instruction by theuser; and accepting the validation command by a second user input tovalidate the suggested control instruction, wherein the fluidadministration device is configured to deliver the insulin dose to thepatient according to the validated control instruction.
 23. The methodas claimed in claim 22, further comprising the steps of: displaying agraphical element permitting a selection of an intensity level of theselected activity; and displaying a graphical element permitting aselection of a duration of the selected activity.
 24. The method asclaimed in claim 22, further comprising the steps of: receiving datafrom a sensor for recording movements of the patient; receiving data ona blood glucose measurement; and displaying the data on the graphicaluser interface.
 25. The method as claimed in claim 22, furthercomprising the step of: displaying a graphical element permitting aselection a quantity of the selected type of meal taken by the patient.26. The method as claimed in claim 25, wherein the quantity taken by thepatient is a relative quantity in relation to a quantity usually takenby the patient.
 27. The method as claimed in claim 22, wherein theactivity of the patient is a temporary physical activity, the methodfurther comprising the step of: displaying at least one of a level ofeffort and a duration of the temporary physical activity performed bythe patient.
 28. The method as claimed in claim 22, further comprisingthe steps of: displaying command icons for increasing and decreasing avalue of the suggested control instruction by predefined incrementswhile simultaneously displaying the suggested control instruction; andpermitting an adjustment to the suggested control instruction.
 29. Themethod as claimed in claim 22, further comprising the step of:displaying a basal rate profile of the suggested control instructionwhile simultaneously displaying the validation command.
 30. The methodas claimed in claim 22, wherein the type of meal includes at least oneof a breakfast, lunch, dinner, supper and snack.
 31. The method asclaimed in claim 30, further comprising the step of: permitting aselection and graphically suggesting a selection of an element of thesecond list depending on the type of meal previously taken or selectedby the patient.